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Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

21 de julio de 2020 actualizado por: Christoph Czernik, Charite University, Berlin, Germany

Nasal High Frequency Oscillation Ventilation Versus Nasal Continuous Positive Airway Pressure to Reduce Post-extubation pCO2 in Very Low Birth Weight Infants: a Randomized Controlled Trial

To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.

Intervention and treatment protocol as described for the two study arms.

Definition of treatment failure (infant meets at least one criterion):

  • Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
  • Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
  • Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").

Sample size:

Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.

Randomization:

Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.

Data monitoring:

By an independent statistician.

Tipo de estudio

Intervencionista

Inscripción (Actual)

6

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • Dpt. of Neonatology, Charité - Universitätsmedizin Berlin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 días a 4 semanas (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Gestational age <32+0 weeks
  • Birth weight <1500 g
  • Received mechanical ventilation via an endotracheal tube for ≥120 h
  • Caffeine treatment according to unit guidelines
  • paCO2 <65 mmHg with pH >7.2
  • FiO2 25-40% to maintain SpO2 at 90-94%.
  • Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
  • Decision of the attending clinician to extubate

Exclusion Criteria:

  • Major congenital malformation requiring surgery
  • Duct-dependent congenital heart disease
  • Neuromuscular disease
  • Participation in another randomized controlled trial
  • Death before reaching the eligibility criteria
  • Hydrocortisone treatment at the time of enrolment
  • Chronological age >28 days

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: nHFOV

Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.

The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.

For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.
Dispositivo: nHFOV
Extubation to ventilator-derived nHFOV using binasal prongs
Comparador activo: nCPAP

Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.

The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.

For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician.
Dispositivo: nCPAP
Extubation to ventilator-derived nCPAP using binasal prongs

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
paCO2 at 72 h After Extubation
Periodo de tiempo: 64 h to 80 h
Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
64 h to 80 h

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pH at 2 h After Extubation
Periodo de tiempo: within the first 6 h after extubation
within the first 6 h after extubation
paO2 at 2 h After Extubation
Periodo de tiempo: within the first 6 h after extubation
within the first 6 h after extubation
paCO2 at 2 h After Extubation
Periodo de tiempo: within the first 6 h after extubation
within the first 6 h after extubation
Base Excess at 2 h After Extubation
Periodo de tiempo: within the first 6 h after extubation
within the first 6 h after extubation
pH at 72 h After Extubation
Periodo de tiempo: 64-80 h after extubation
64-80 h after extubation
paO2 at 72 h After Extubation
Periodo de tiempo: 64-80 h after extubation
64-80 h after extubation
Base Excess at 72 h After Extubation
Periodo de tiempo: 64-80 h after extubation
64-80 h after extubation
Successful Extubation
Periodo de tiempo: 72 h after extubation
Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"
72 h after extubation
Treatment Failure
Periodo de tiempo: within 7 days after extubation
Defined as the number of patients reaching the criterion of "treatment failure"
within 7 days after extubation
Reintubation
Periodo de tiempo: within 7 days after extubation
Defined as the number of patients being reintubated
within 7 days after extubation
Highly Viscous Secretions
Periodo de tiempo: within 72 hours after extubation
Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient
within 72 hours after extubation
Other Adverse Effects
Periodo de tiempo: until discharge
Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia
until discharge
Duration of Respiratory Support
Periodo de tiempo: until discharge
Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen
until discharge

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
pH at 2 h After Switch to "Rescue Treatment"
Periodo de tiempo: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paO2 at 2 h After Switch to "Rescue Treatment"
Periodo de tiempo: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paCO2 at 2 h After Switch to "Rescue Treatment"
Periodo de tiempo: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Base Excess at 2 h After Switch to "Rescue Treatment"
Periodo de tiempo: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Successful Rescue
Periodo de tiempo: 72 h after switch to "rescue" treatment
Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"
72 h after switch to "rescue" treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Charite University, Berlin, Germany

Investigadores

  • Investigador principal: Christoph Czernik, MD PhD, Charite University, Berlin, Germany

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2015

Finalización primaria (Actual)

31 de diciembre de 2017

Finalización del estudio (Actual)

31 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

10 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2015

Publicado por primera vez (Estimar)

16 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de agosto de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EA2/011/12

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